Obesity, AbdominalRACCRPPTNCT02217423
Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy
A study testing Chest physiotherapy chest wall expansion and Chest physiotherapy airway clearance modality in people with Obesity, Abdominal and Lung Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Lung Disease
- What is being tested?
- Chest physiotherapy chest wall expansion and Chest physiotherapy airway clearance modality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients (> 18 years old), clinical stability characterized by axillary body temperature below 38 ° C, hemoglobin higher than 7 g / dL, oxygen saturation by pulse oximetry greater than or equal to 88%, mean arterial pressure (MAP) greater than 70 or less than 120 mm Hg, heart rate between 50 bpm to 140 bpm ; ability to understand, carry out the commands appropriately for evaluative tests, with the Glasgow Coma Scale score greater than 8, locomotor integrity of the lower limbs, spontaneous breathing, lack of hospital physiotherapy during hospitalization, prescription for respiratory therapy; bronchodilator, if applicable four hours before intervention.
Who cannot join
- inadequate perform to the maneuvers of the evaluation (e.g. spirometry), hemodynamic instability, thoracic dermal injury, disabling orthopedic complications that compromise the techniques of assessment and intervention, lymphedema of the trunk; sudden weight gain with edema in limbs, ascites, nephrotic syndrome, congestive heart failure, liver cirrhosis, erysipelas, deep vein thrombosis, heart bypass, heart transplantation, arrhythmias, atrioventricular block, severe dyspnea (Borg> 5), spinal cord injury, hemoptysis, osteoporosis, recent surgeries, coagulopathy, bronchopleural fistula, subcutaneous emphysema, presence of diabetes mellitus associated with cardiac autonomic dysfunction, bronchoconstriction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Abdominal Circumference and Cardiorespiratory Repercussions in Hospitalized Patients Submitted to Physical Therapy
The purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy.
Read the detailed description
The physiotherapist assessment will consist of anthropometry (body mass index, abdominal circumference, adipometer); chest inspection and palpation, vital signs (blood pressure, heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be divided into four groups according to waist circumference (increased or not, with respect to cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this assessment, chest physical therapy will begin according to the protocol for obstructive and restrictive respiratory disorders. The treatment will have an average duration of 30 minutes. At the end of treatment (single session) the patient will be assessed again after five and thirty minutes.
- Conditions
- Obesity, Abdominal, Lung Disease
- Being tested
- Chest physiotherapy chest wall expansion, Chest physiotherapy airway clearance modality
- Keywords
- Physical Therapy Modalities, Respiration Disorders, Respiratory Therapy
- Medical subject headings
- Obesity, Abdominal, Lung Diseases, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy chest wall expansionOther
Also called Chest physiotherapy
chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).
Chest physiotherapy airway clearance modalityOther
Also called Chest physical therapy
The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive increased AC | Experimental | Patient with obstructive respiratory disease with increased abdominal circumference.
chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough. Receives: Other: Chest physiotherapy airway clearance modality |
| Obstructive disfunction with normal AC | Experimental | Patients with obstructive respiratory disease with normal abdominal circumference.
Patient with obstructive respiratory disease with increased abdominal circumference.
chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough. Receives: Other: Chest physiotherapy airway clearance modality |
| Restrictive increased AC | Experimental | Patients with restrictive respiratory disease with increased abdominal circumference. chest physiotherapy chest wall expansion.
The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry. Receives: Other: Chest physiotherapy chest wall expansion |
| Restrictive disfunction with normal AC | Experimental | Patients with restrictive respiratory disease with normal abdominal circumference.
Chest physiotherapy chest wall expansion. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry. Receives: Other: Chest physiotherapy chest wall expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in spirometric measures.
The spirometry is used to assess chest volume and capacity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second.
Measured: Baseline, five and thirty minutes.
Secondary outcomes (1)
Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.
The pulse oxymetry or pulse oximeter is used to measure peripheral oxygen saturation.
The arterial blood pressure (systolic and diastolic) will be measured by sphygmomanometer to follow the displacement.
Measured: Baseline, five and thirty minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Martinelli, Universidade Federal de Sao Carlos
- Investigators
- Bruno Martinelli, Me, Principal investigator, UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217423
- Sponsor's protocol ID
- 34609514100005502
- Acronym
- RACCRPPT
- Status last verified
- Dec 2015
- First submitted
- 12 Aug 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Abdominal Circumference and Cardiorespiratory Repercussions in Hospitalized Patients Submitted to Physical Therapy
- ClinicalTrials.gov ID
- NCT02217423
- Acronym / sponsor ID
- RACCRPPT / 34609514100005502
- Conditions
- Obesity, Abdominal, Lung Disease
- Keywords
- Physical Therapy Modalities, Respiration Disorders, Respiratory Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy.
Detailed description
The physiotherapist assessment will consist of anthropometry (body mass index, abdominal circumference, adipometer); chest inspection and palpation, vital signs (blood pressure, heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be divided into four groups according to waist circumference (increased or not, with respect to cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this assessment, chest physical therapy will begin according to the protocol for obstructive and restrictive respiratory disorders. The treatment will have an average duration of 30 minutes. At the end of treatment (single session) the patient will be assessed again after five and thirty minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obstructive increased AC | Experimental | Other: Chest physiotherapy airway clearance modalityPatient with obstructive respiratory disease with increased abdominal circumference. chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough. |
| Obstructive disfunction with normal AC | Experimental | Other: Chest physiotherapy airway clearance modalityPatients with obstructive respiratory disease with normal abdominal circumference. Patient with obstructive respiratory disease with increased abdominal circumference. chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough. |
| Restrictive increased AC | Experimental | Other: Chest physiotherapy chest wall expansionPatients with restrictive respiratory disease with increased abdominal circumference. chest physiotherapy chest wall expansion. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry. |
| Restrictive disfunction with normal AC | Experimental | Other: Chest physiotherapy chest wall expansionPatients with restrictive respiratory disease with normal abdominal circumference. Chest physiotherapy chest wall expansion. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (> 18 years old), clinical stability characterized by axillary body temperature below 38 ° C, hemoglobin higher than 7 g / dL, oxygen saturation by pulse oximetry greater than or equal to 88%, mean arterial pressure (MAP) greater than 70 or less than 120 mm Hg, heart rate between 50 bpm to 140 bpm ; ability to understand, carry out the commands appropriately for evaluative tests, with the Glasgow Coma Scale score greater than 8, locomotor integrity of the lower limbs, spontaneous breathing, lack of hospital physiotherapy during hospitalization, prescription for respiratory therapy; bronchodilator, if applicable four hours before intervention.
Key exclusion criteria (1 listed)
- inadequate perform to the maneuvers of the evaluation (e.g. spirometry), hemodynamic instability, thoracic dermal injury, disabling orthopedic complications that compromise the techniques of assessment and intervention, lymphedema of the trunk; sudden weight gain with edema in limbs, ascites, nephrotic syndrome, congestive heart failure, liver cirrhosis, erysipelas, deep vein thrombosis, heart bypass, heart transplantation, arrhythmias, atrioventricular block, severe dyspnea (Borg> 5), spinal cord injury, hemoptysis, osteoporosis, recent surgeries, coagulopathy, bronchopleural fistula, subcutaneous emphysema, presence of diabetes mellitus associated with cardiac autonomic dysfunction, bronchoconstriction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy chest wall expansionAlso: Chest physiotherapychest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry). | Other | Restrictive disfunction with normal AC, Restrictive increased AC |
| Chest physiotherapy airway clearance modalityAlso: Chest physical therapyThe protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough. | Other | Obstructive disfunction with normal AC, Obstructive increased AC |
Primary outcome
Change from baseline in spirometric measures.
Time frame: Baseline, five and thirty minutes.
The spirometry is used to assess chest volume and capacity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second.
1 secondary outcome
Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.
Time frame: Baseline, five and thirty minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Martinelli, Me principal investigator
UFSCar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy chest wall expansion and Chest physiotherapy airway clearance modality in people with Obesity, Abdominal and Lung Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in spirometric measures. (time frame: Baseline, five and thirty minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.